A Study With RO4917523 in Patients With Fragile X Syndrome

A Randomized, Double-blind, Placebo-controlled, Pharmacokinetic, Safety and Tolerability, and Exploratory Efficacy and Pharmacodynamic Effects Study of RO4917523 in Adult Patients With Fragile X Syndrome.

This randomized, double-blind multiple ascending dose study will evaluate the safety and tolerability, pharmacokinetics and efficacy of RO4917523 in patients with Fragile X Syndrome. The patients will be randomized to receive either active drug or placebo. The anticipated time on study treatment is 6 weeks. The target sample size is <100 patients.

Inclusion Criteria:

• Adult patients, 18 to 50 years of age
• Fragile X Syndrome
• IQ less than 75
• Reliable caregiver

Exclusion Criteria:

• Current psychosis or presumption of psychosis
• History of suicidal behavior or considered a high suicidal risk
• Severe self-injurious behavior
• Any unstable medical condition other than Fragile X Syndrome (e.g. hypertension, diabetes)
• Current seizure disorder